A novel cell therapy to treat patients with hepatitis C virus (HCV)infection.

Phase 1

Completed

• Conditions: Hepatitis C virus infection; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Infection - Other infectious diseases; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12610000067077
• Lead Sponsor: Eric J Gowans

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

HCV ribonuclei acid (RNA) positive for >6 months.
Previously failed interferon-based therapy
Infected with genotype 1 virus.

Exclusion Criteria

Hepatitis B virus (HBV)-positive
Human immunodeficiency virus (HIV)-positive
Evidence of autoimmunity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety.<br>Clinical examination.<br>Haematology-full blood examination<br>Clinical chemistry-full study, including liver function tests (LFT).<br>HCV viral load.[Weekly during intervention and weekly for 6 weeks after intervention.]

Secondary Outcome Measures

Name	Time	Method
Induction of HCV-specific cell mediated immunity.<br>This will be assessed by Enzyme-linked immunosorbent spot (ELIspot) examination of peripheral blood mononuclear cells (PBMC) using HCV peptide pools as the stimulating antigen.<br>The viral load will be assessed by reverse transcriptase-polymerase chain reaction (RT-PCR).[Weekly during intervention and weekly for 6 weeks after intervention.]